A pharmaceutical and biotechnology corrective action and preventive action system especially designed for the overall effort to investigate and correct quality issues to prevent recurrence is an important principle under the Current Good Manufacturing Practices (CGMP) found in 21 CFR Parts 210-211, which cover the pharmaceutical and biotechnology industries.

Although the regulation does not use the term "CAPA," Section 211.192 essentially requires CAPA by mandating a thorough investigation of any discrepancy or failure of a batch (or any of its components) to meet specifications. It also requires a written record of the investigation, including conclusions and follow-up which is available in specialized systems like the pharmaceutical and biotechnology CAPA software offered by MasterControl.

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Pharmaceutical and biotechnology companies are keenly aware of the time and effort required to build their reputation in the market. In today's highly competitive market, it is a company's reputation that provides the leverage needed to make sales and boost ROI. The quality standards maintained by companies through their manufacturing methods dictate the reputation they enjoy. It is crucial to follow certain protocols for maintaining and sustaining a certain level of quality in manufacturing products.

The issues that surface during the establishment of business processes are a major reason of financial drains and customer dissatisfaction, which is why competitive companies are incorporating corrective action (CAPA) software into their quality management systems for correcting issues as soon as they surface. To continually improve business practices, MasterControl has specifically designed a pharmaceutical and biotechnology CAPA system that is aids companies in rectifying issues as per the standards laid out by the FDA (21 CFR Part 11) and ISO regulatory bodies.

CAPA is a necessary tool that must be in the foundation of every quality system. The basis of any CAPA is solid documentation that provides the minutest details of the non-conformance, root cause, and process problems. MasterControl's pharmaceutical and biotechnology CAPA software is completely online, enabling customers, vendors, and other various users to contribute to the discussions related to finding solutions for the issues prevalent in the business. The online documentation helps identify the reasons behind an issue's occurrence and the possible remedies to prevent recurrence.

The MasterControl pharmaceutical and biotechnology CAPA system allows authorized users to participate in documenting issues and associated resolutions that are then routed for electronic signature and approval before being "locked" in virtual vaults. This eliminates the possibility of accessing outdated CAPA documents for reference since at any time only the updated version of a document is available for use as a current operating procedure. Users may collaborate in the documentation of a CAPA process in order to monitor and tackle issues that surface throughout the enterprise. Authorized users can document CAPA processes in offline mode and then go online to sync the documents so that the latest documents are available for issue resolution at any given time.

A healthy CAPA program not only resolves issues but also provides management with the facility of integrating CAPA with other quality processes in the system. A CAPA is usually triggered on the basis of an issue that is traced during an audit, for instance. This requires transferring the audit findings into a separate CAPA form and launching the appropriate CAPA for issue resolution. Programs in hybrid or paper based systems reside in isolated silos, making it extremely difficult for management to connect processes together. MasterControl's integrated pharmaceutical and biotechnology CAPA software is completely automated and can be triggered through Form 483 findings, quality audits, customer complaints, or some other source.

The main CAPA objective is served through MasterControl's closed loop solution that is robust yet flexible, as per the business requirements of the company. Different customizable forms are available out of the box with MasterControl pharmaceutical and biotechnology CAPA software so that the management is better equipped in operating the CAPA process without any hassle. For example, an "8D" process form guides the quality team through every step of CAPA implementation starting from problem identification, to investigation of its root cause, through problem resolution and prevention of its recurrence.

One of the basic reasons for incorporating the CAPA process within any company's system is to view the data and findings retrieved through an audit and devise ways for the business to improve. Manual collection of customer complaints, deviations, events, and other incidents can never guarantee the management that the data captured is entirely accurate as there is always a risk of data loss. Since data is collected through multiple sources, it is important to capture data accurately without any errors. MasterControl pharmaceutical and biotechnology corrective action systems ensure that data from multiple sources is collected properly through the use of a specific CAPA form, which can be launched from other forms to streamline the entire CAPA process. Links are maintained so users can review a completed process and easily see what triggered the CAPA.

The CAPA process is about evaluating the problems, determining their root causes, developing an action plan to correct the problems, and implementing the plan. With MasterControl pharmaceutical and biotechnology corrective action software, management is provided with the most accurate representation of the actual problems that are then logically analyzed to deduce results. These results serve as the basis for deriving remedies that are implemented to correct the issues. The advanced analytics and reporting capabilities built into the MasterControl system include customizable reports and online charting for managers to get a real-time view of the CAPA process that allow them to be more proactive about improving their quality system.

Management can group data in reports by a date interval and then chart the data over a date range. Users can also summarize data on multiple levels to bring order to the data representation according to specific organizational needs.

To Learn More About MasterControl's Pharmaceutical and Biotechnology CAPA Software

To learn more about our pharmaceutical and biotechnology CAPA software contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.